1. Technical Field
The devices and methods described herein relate generally to the field of medicine and more particularly to the fields of sleep and pulmonary medicine being useful for the treatment of diseases of air flow including snoring, sleep apnea and other breathing disorders.
2. Background
The mechanism of collapse of the airway that occurs during some stages of sleep is due to a general relaxation of the muscles that stabilize the upper airway segment. Snoring, in general, is the vibration of relaxed respiratory structures. The obstructive sleep apnea (OSA) syndrome afflicts 3% of the general population and is due to episodic upper airway obstruction during sleep. Invasive treatments of OSA includes such surgical interventions as tracheostomy, uvalopalatopharyngoplasty, and maxillo-facial reconstruction. In general, medical therapy has been unproductive. The current non-invasive standard for treatment of breathing disorders is Continuous Positive Airway Pressure (CPAP) either performed nasally and/or intraorally: for example, U.S. Pat. No. 4,249,527 to Ko and U.S. Pat. No. 4,944,310 to Sullivan demonstrate methods and devices for CPAP. Mask discomfort, nasal congestion, nasal dryness, eye irritation, leakage of air through the mouth or nose (CPAP requires the maintenance of pressure) are very common problems for patients new to CPAP and other high pressure systems. CPAP has very poor patient compliance.
The prior art also includes devices containing electrodes for treating respiratory conditions. There are two methods in which electromuscular stimulation can be applied to a patient; invasively or non-invasively. Invasive electrical stimulation of a muscle involves implanting one or more electrodes, either permanently or temporarily within the patient. Non-invasive electrical stimulation of the muscles in the upper airway involves placing an electrode in direct contact with a surface of the patient and passing a current through the surface tissues adjacent the electrode: for example, U.S. Pat. No. 4,830,008 to Meer exhibits electrical stimulation to nerves and U.S. Pat. No. 5,284,161 issued to Karell exhibits a device for increasing muscle tone with electrodes applied to the soft palate in a removable dental appliance.
Airway patency depends on the activity of the pharyngeal dilator muscles. Common sites of obstruction are behind the tongue and at the level of the soft palate; hence, the reason for electrical stimulation to the soft palate to increase muscle tone. The muscles of the tongue, especially the posterior fibers of the genioglossus, draw the base of the tongue forward and anteriorly. One or more of the muscles of the tongue and/or mouth and/or pharynx and/or larynx normally contract reflexively during inspiration. OSA sufferers experience reduced muscle tone during sleep as compared to non-OSA patients, thereby causing a reduction in airway patency. Stimulation of one or more of the above structures improves airway dilatation. Airways that would normally collapse during respiration remain open when the patient breathes through pursed-lips, which is helpful in chronic obstructive pulmonary disease (COPD) and other respiratory conditions. Pursing lips produces expiratory resistance via proximal obstruction, that is, (Positive Expiratory End Pressure, PEEP). Pursing lip therapy is commonly used in daily medical practice.
What is missing in the prior art is the combination use of electrical stimulation and nasal or oral respiratory methods and devices. A combination effect is beneficial. The prior art does include U.S. Pat. No. 5,792,067 to Karell that contains electrodes and an airway; however, the Karell patent lacks the ability to include the nasal cavity; it also lacks the ability to include resistance in air passageways.
The following are examples of prior art which may be useful in the understanding of the utility of the instant invention.
U.S. Pat. No. RE36120 to Karell entitled “SNOPPER—THE SNORING STOPPER ANTI-SNORING MOUTH DEVICE” is described and the entire disclosure of which is incorporated herein by reference.
U.S. Pat. No. 5,792,067 to Karell entitled “APPARATUS AND METHOD FOR MITIGATING SLEEP AND OTHER DISORDERS THROUGH ELECTROMUSCULAR STIMULATION” is described and the entire disclosure of which is incorporated herein by reference.
U.S. Pat. No. 6,212,435 to Lattner et al. entitled “INTRAORAL ELECTROMUSCULAR STIMULATION DEVICE AND METHOD” is described and the entire disclosure of which is incorporated herein by reference.
U.S. Pat. No. 6,618,627 to Lattner et al. entitled “INTRAORAL ELECTROMUSCULAR STIMULATION DEVICE AND METHOD” is described and the entire disclosure of which is incorporated herein by reference.
U.S. Pat. No. 6,209,542 to Thornton entitled “COMBINATION FACE MASK AND DENTAL DEVICE FOR IMPROVED BREATHING DURING SLEEP” is described and the entire disclosure of which is incorporated herein by reference.
International Patent Application PCT/US2005/044888 by Doshi et al. entitled “RESPIRATORY DEVICES AND METHODS OF USE” is described and the entire disclosure of which is incorporated herein by reference.